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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1177-01
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/18/2023
Event Type  malfunction  
Event Description
It was reported that balloon deflation issues occurred.The target lesion was located in the popliteal artery p2 segment.A 5.0 mm x 80 mm, 80 cm ranger drug-coated balloon was selected for a percutaneous transluminal angioplasty procedure.The balloon was inflated to a pressure of 12 atmospheres, but when deflating, there were balloon deflation issues encountered.The balloon was able to be removed fully deflated via the inserted sheath.The procedure was completed successfully with no patient complications.The patient status was good post-procedure.
 
Event Description
It was reported that balloon deflation issues occurred.The target lesion was located in the popliteal artery p2 segment.A 5.0 mm x 80 mm, 80 cm ranger drug-coated balloon was selected for a percutaneous transluminal angioplasty procedure.The balloon was inflated to a pressure of 12 atmospheres, but when deflating, there were balloon deflation issues encountered.The balloon was able to be removed fully deflated via the inserted sheath.The procedure was completed successfully with no patient complications.The patient status was good post-procedure.
 
Manufacturer Narrative
Device evaluation by manufacturer: returned product consisted of a ranger drug coated balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.Functional testing was performed by inflating the device to rated burst pressure then deflating it.There were no issues deflating the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damages that could have contributed to the reported event and there were no issues deflating the balloon.
 
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Brand Name
RANGER
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
HEMOTEQ AG
adenauerstrasse 15
wuerselen 52146
GM   52146
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17923252
MDR Text Key325862945
Report Number2124215-2023-56039
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1177-01
Device Catalogue Number1177-01
Device Lot Number02048H23
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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